• ICT Security & Compliance (ISO27001, SOC2, NIS2, GDPR, DPDP, etc)
• Implementation norms & regulations, monitor & continuous improvement
• Develop, maintain Policies, procedures and guidelines
• Conduct Risk Assessments (ISO 27005)
• Review and strengthen the company?s data protection (DPIA, ROPA; etc)
• Provide expert advisory support during certification, interna & customers audits.
• Implement supplier relationships process (Control 5.19) 

• Validate IT systems  
• Define Project Documentation list
• Author Valida on Risk Assessment, Validation Plan, review other system deliverables such URS, FS, CS/DS, IQ, OQ, PQ, FRA, DIRA, Tests (QALM), Reports 
• Review Decommissioning/Retirement Plan and Report 
• Ensure that data migra on is executed in a controlled manner, executed in a controlled manner, executed data Migration Plan / Report 
• Provide input on project progression/ status to the management / Project Manager on periodic basis 
• Flag issues concerns, challenges related to system validation and operational activities 
• Support operational activities such as Change Management (QMS & ITMS), Deviation Management, Periodic Reviews, conduct internal Audits, etc 
• Working in the IT QMS environment (CSV, data integrity, GDPR, ISO27001, NIS2, NIST, BCP, DRP, Digital Governance, etc) 

• In Quality department that supports R&D, in collaboration with Tech and the business
• Support the validation of Systems essentially validated systems TEC (platform implementation, SAP, LIMS Labware, Artificial Intelligence, PLC implementation, etc)
• Support R&D teams to speed up their processes and simplify their activities: 
  • System Valida on Support 
  • Business Process 
  • Quality System is used efficiently (CAPA, Change Control, etc.)
• Collaborate on the implementation of new technologies and processes
• Helping to set up the Tec Tools, deal with system customisations
• ITIL : Change, Incident and Problem Management 

• Lead or collaboratetion IT Quality projects to implement, change or upgrade CS systems and processes
• Support local BIS Leads as Subject Matter Expert and provide global guidance
• Create, review and manage the designated System Deliverables and/or validation deliverables
• Support GxP-determina on and validation activities for global CS systems
• Evaluate, test, and validate soware and CS services Support the creation of system, ITSM SOPs as author, reviewer, or expert
• Analyse deficiencies in service or performance and recommend product or service improvements to address problems Ensure computerized systems comply with applicable GxP, regulatory and corporate requirements throughout the life cycle of the systems
• Designs and implements defect reduction programs
• Primary contact with cloud services providers (Veeva Vault (DMS, Changes, Deviation, DocuSign, Etmf modules)
• Support organization on maintain ISO27001 compliance 
• Provide advice on security measures and risk treatment

• Key QA contact for Computerized System valida on activities, including new projects and gap resolution of existing systems (implementation of CSV)
• Quality review and approval of Computerized System (CS)
• Development of supplier assessment questionnaire (ISO27001, CSV, Data Integrity)
• Assess suppliers, evaluates questionnaires, review contracts, etc
• Primary contact with services & products suppliers
• Quality review and approval of User Requirement Specifications (URS), Qualification and validation files related to CS in GXP environment (IOPQ, VSR, etc)
• Quality expert in new digitaliza on project in GxP environment 

QA Manager (ISO 9001)

• Implementation of the QMS according ISO 9001:2015
• Perform Gap Analysis
• Established Business Processing Plan

Data Protec on Manager Associate (GDPR & HIPPA)

• Project management and coordina on Business meetings participation with clients
• Perform Data Protection Gap Analysis (DPGA) Perform Data Protec on Impact Assessment (DPIA)
• Advise clients on organizational & technical measures they should implement (ISO27001, NIS, NIST, etc) 

• Supervise and support the activities related to Quality Systems for the Lessines facility, mainly Change Control Management system, Documentation system and Quality Improvement Plan 
• Ensure and maintain compliance with current regula ons/requirements of Quality System including paper raw data management.
• Define, review and analyze Quality Systems? metrics. Define appropriate actions to maintain satisfactory metrics.

• Perform validation IQ/OQ/PQ on Lab Equipment and Information System
• Writing qualification protocols (URS, ORA, LE&IS, system configuration, VMP, etc.)
• Implementa on of a LIMS (LabVantage) Provide LIMS training to the Laboratory team 

• Configuration of the LIMS (Labware) according the business & regulatory requirements
• User management
• Technical support on issues (devia ons, CAPA, etc)
• Providing training to the end users